Assessment of the Feasibility of a SOTI With Hypoallergenic (H.A.) Cereals in Children With Diagnosed IgE-mediated Allergy to Wheat
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 4
- 主要终点
- Specific Oral Tolerance Induction (SOTI) with hypoallergenic wheat in children allergic to wheat
研究概览
简要总结
The investigators plan to launch a Specific Oral Tolerance Induction (SOTI) pilot study in order to assess the efficacy and the safety of hypoallergenic (H.A.) wheat cereals, for children with allergy to wheat. The study has the potential to offer a desensitization treatment option for children allergic to wheat.
The investigators hypothesize that H.A. wheat cereals have similar efficacy with less side effects than native wheat cereals.
详细描述
In this pilot study, the investigators aim to assess the feasibility of a SOTI (Specific Oral Tolerance Induction) with hypoallergenic (H.A.) cereals in children with diagnosed IgE-Mediated allergy to wheat.
This is a multi centre, open, pilot study testing 1 product.10 children of any ethnicity aged from 1 to 12 years old with diagnosed allergy to wheat will be eligible to participate in the study. The duration of the treatment will be 6 months with a minimum of 1 month of daily consumption of the hydrolyzed wheat cereals.
Each subject will feed with a quantity of the assigned study product according to the SOTI. The SOTI will be performed at the hospital under the control of qualified doctors and nurses.
The study product is administered starting with very low dosages, which are increased stepwise every 30 minutes up to an amount equivalent to the usual daily oral intake. Thereafter, the study product corresponding to the maximum dose tolerated is given in a maintenance dose in one serve every day until the final visit during which a challenge test with wheat will be performed to assess the tolerance of whole wheat.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infant of any ethnicity aged between 1 to 12 years old at the time of enrollment and
- •Positive Skin Prick Test (SPT) to wheat and/or Positive specific IgE to wheat and
- •Immediate positive reaction (IgE-type reaction) to wheat as shown by provocation test done a maximum 1 year before the enrollment to the study or an unambiguous history for wheat allergy as evaluated by the investigator and
- •Having obtained his/her signed legal representative's informed consent
排除标准
- •Child on systemic drugs (potentially affecting the allergic reactions e.g. antihistamines) according to half-life at time of enrollment or
- •Congenital illness or malformation that may affect normal growth (especially immunodeficiency) or
- •Child with uncontrolled asthma or
- •Child whose parents/caregivers cannot be expected to comply with treatment or
- •Child currently participating in another interventional clinical trial.
结局指标
主要结局
Specific Oral Tolerance Induction (SOTI) with hypoallergenic wheat in children allergic to wheat
时间窗: 6 months
The primary outcome is to document Clinical examination for presence or absence of immediate adverse reaction during the SOTI with evaluation of the maximum dose tolerated during the SOTI. Symptoms related to allergic reactions during the SOTI (if applicable)will be recorded in the CRF.
次要结局
- assess allergic reactions to a challenge test to wheat(6 months)